Ostomy appliance with layered base plate

ABSTRACT

A base plate of an ostomy appliance includes a first adhesive layer and a masking element. The first adhesive layer includes a stomal opening with a center point and a proximal surface configured to be attached to a skin surface of a user. The masking element is arranged on a distal surface of the first adhesive layer and is more insulative than the first adhesive layer. A plurality of electrodes is arranged on the distal surface of the first adhesive layer, where each electrode includes a sensing part and a conductor part. The masking element is arranged between the conductor part of each electrode and the first adhesive layer. The electrodes are formed on a proximal surface of a support layer.

TECHNICAL FIELD

The present disclosure relates to an ostomy system, devices thereof andmethod for manufacturing an ostomy appliance. The ostomy appliancesystem comprises an ostomy appliance and an ostomy monitor device. Inparticular, the present disclosure relates to a base plate of an ostomyappliance including electrodes for detecting and monitoring theoperation of an ostomy appliance.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated into and a part ofthis specification. The drawings illustrate embodiments and togetherwith the description serve to explain principles of embodiments. Otherembodiments and many of the intended advantages of embodiments will bereadily appreciated as they become better understood by reference to thefollowing detailed description. The elements of the drawings are notnecessarily to scale relative to each other. Like reference numeralsdesignate corresponding similar parts.

FIG. 1 illustrates an exemplary ostomy system,

FIG. 2 illustrates an exemplary monitor device of the ostomy system,

FIG. 3 is an exploded view of a base plate of an ostomy appliance,

FIG. 4 is an exploded view of an exemplary electrode assembly,

FIG. 5 is a proximal view of parts of a base plate,

FIG. 6 is a distal view of an exemplary electrode configuration,

FIG. 7 is a distal view of an exemplary masking element,

FIG. 8 is a distal view of an exemplary first adhesive layer,

FIG. 9 is a proximal view of the first adhesive layer of FIG. 8 ,

FIG. 10 is a distal view of a part of the base plate including monitorinterface.

DETAILED DESCRIPTION

Various exemplary embodiments and details are described hereinafter,with reference to the figures when relevant. It should be noted that thefigures may or may not be drawn to scale and that elements of similarstructures or functions are represented by like reference numeralsthroughout the figures. It should also be noted that the figures areonly intended to facilitate the description of the embodiments. They arenot intended as an exhaustive description of the invention or as alimitation on the scope of the invention. In addition, an illustratedembodiment needs not have all the aspects or advantages shown. An aspector an advantage described in conjunction with a particular embodiment isnot necessarily limited to that embodiment and can be practiced in anyother embodiments even if not so illustrated, or if not so explicitlydescribed.

Throughout this disclosure, the words “stoma” and “ostomy” are used todenote a surgically created opening bypassing the intestines or urinarytract system of a person. The words are used interchangeably, and nodifferentiated meaning is intended. The same applies for any words orphrases derived from these, e.g. “stomal”, “ostomies” etc. Also, thesolid and liquid wastes emanating from the stoma may be referred to asboth stomal “output,” “waste(s),” and “fluids” interchangeably. Asubject having undergone ostomy surgery may be referred to as “ostomist”or “ostomate”—moreover, also as “patient” or “user”. However, in somecases “user” may also relate or refer to a health care professional(HCP), such as a surgeon or an ostomy care nurse or others. In thosecases, it will either be explicitly stated, or be implicit from thecontext that the “user” is not the “patient” him- or herself.

In the following, whenever referring to proximal side or surface of alayer, an element, a device or part of a device, the referral is to theskin-facing side or surface, when a user wears the ostomy appliance.Likewise, whenever referring to the distal side or surface of a layer,an element, a device or part of a device, the referral is to the side orsurface facing away from the skin, when a user wears the ostomyappliance. In other words, the proximal side or surface is the side orsurface closest to the user, when the appliance is fitted on a user andthe distal side is the opposite side or surface—the side or surfacefurthest away from the user in use.

The axial direction is defined as the direction of the stoma, when auser wears the appliance. Thus, the axial direction is generallyperpendicular to the skin or abdominal surface of the user.

The radial direction is defined as perpendicular to the axial direction.In some sentences, the words “inner” and “outer” may be used. Thesequalifiers should generally be perceived with respect to the radialdirection, such that a reference to an “outer” element means that theelement is farther away from a centre portion of the ostomy appliancethan an element referenced as “inner”. In addition, “innermost” shouldbe interpreted as the portion of a component forming a centre of thecomponent and/or being adjacent to the centre of the component. Inanalogy, “outermost” should be interpreted as a portion of a componentforming an outer edge or outer contour of a component and/or beingadjacent to that outer edge or outer contour.

The use of the word “substantially” as a qualifier to certain featuresor effects in this disclosure is intended to simply mean that anydeviations are within tolerances that would normally be expected by theskilled person in the relevant field.

The use of the word “generally” as a qualifier to certain features oreffects in this disclosure is intended to simply mean—for a structuralfeature: that a majority or major portion of such feature exhibits thecharacteristic in question, and—for a functional feature or an effect:that a majority of outcomes involving the characteristic provide theeffect, but that exceptionally outcomes do no provide the effect.

The present disclosure relates to an ostomy system and devices thereof,such as an ostomy appliance, a base plate for an ostomy appliance, amonitor device, and optionally one or more accessory devices. Further,methods related to the ostomy system and devices thereof are disclosed.An accessory device (also referred to as an external device) may be amobile phone or other handheld device. An accessory device may be apersonal electronic device, e.g. a wearable, such as a watch or otherwrist-worn electronic device. An accessory device may be a dockingstation. The docking station may be configured to electrically and/ormechanically couple the monitor device to the docking station. Thedocking station may be configured for charging the monitor device and/orconfigured for transferring data between the monitor device and thedocking station. The ostomy system may comprise a server device. Theserver device may be operated and/or controlled by the ostomy appliancemanufacturer, the accessory device, and/or a service centre.

The present disclosure provides an ostomy system and devices thereof,such as an ostomy appliance, a base plate for an ostomy appliance, amonitor device, and optionally one or more accessory devices whicheither alone or together facilitate reliable determination of thenature, severity and rapidness of moisture propagation in the adhesivematerial provided for attaching the base plate to the skin surface of auser. Depending on the nature of the pattern of moisture propagation inthe adhesive, the ostomy system and devices thereof enable providinginformation to the user about the type of failure, and in turn enableproviding an indication to the user of the severity and thus theremaining time frame for replacing the ostomy appliance withoutexperiencing severe leakage and/or skin damage.

The ostomy appliance comprises a base plate and an ostomy pouch (alsoreferred to as an ostomy bag). The ostomy appliance may be a colostomyappliance, an ileostomy appliance or a urostomy appliance. The ostomyappliance may be a two-part ostomy appliance, i.e. the base plate andthe ostomy pouch may be releasably coupled e.g. with a mechanical and/oran adhesive coupling, e.g. to allow that a plurality of ostomy pouchescan be utilized (exchanged) with one base plate. Further, a two-partostomy appliance may facilitate correct application of the base plate toskin, e.g. to an improved user sight of the stomal region. The ostomyappliance may be a one-part ostomy appliance, i.e. the base plate andthe ostomy pouch may be fixedly attached to each other. The base plateis configured for coupling to a user's stoma and/or skin surrounding thestoma, such as a peristomal skin area.

The base plate comprises a first adhesive layer, also denoted centeradhesive layer. During use, the first adhesive layer adheres to theuser's skin (peristomal area) and/or to additional seals, such assealing paste, sealing tape and/or sealing ring. Thus, the firstadhesive layer may be configured for attachment of the base plate to theskin surface of a user. The first adhesive layer may have a stomalopening with a center point.

The first adhesive layer may be made of a first composition. The firstcomposition may comprise one or more polyisobutenes and/orstyrene-isoprene-styrene. The first composition may comprise one or morehydrocoloids.

The first composition may be a pressure sensitive adhesive compositionsuitable for medical purposes comprising a rubbery elastomeric base andone or more water soluble or water swellable hydrocolloids. The firstcomposition may comprise one or more polybutenes, one or more styrenecopolymers, one or more hydrocolloids, or any combination thereof. Thecombination of the adhesive properties of the polybutenes and theabsorbing properties of the hydrocolloids renders the first compositionsuitable for use in ostomy appliances. The styrene copolymer may forexample be a styrene-butadiene-styrene block copolymer or astyrene-isoprene-styrene block copolymer. Preferably, one or morestyrene-isoprene-styrene (SIS) block type copolymers are employed. Theamount of styrene block-copolymer may be from 5% to 20% of the totaladhesive composition. The butene component is suitably a conjugatedbutadiene polymer selected from polybutadiene, polyisoprene. Thepolybutenes are preferably present in an amount of from 35-50% of thetotal adhesive composition. Preferably, the polybutene ispolyisobutylene (PIB). Suitable hydrocolloids for incorporation in thefirst composition are selected from naturally occurring hydrocolloids,semisynthetic hydrocolloids and synthetic hydrocolloids. The firstcomposition may comprise 20-60% hydrocolloids. A preferred hydrocolloidis carboxymethylcellulose (CMC). The first composition may optionallycontain other components, such as fillers, tackifiers, plasticizers, andother additives.

The first adhesive layer may have a plurality of sensor point openings.A sensor point opening of the first adhesive layer is optionallyconfigured to overlap a part of an electrode, e.g. to form a sensorpoint.

The sensor point openings of the first adhesive layer may compriseprimary sensor point openings. The primary sensor point openings maycomprise one or more primary first sensor point openings and one or moreprimary second sensor point openings, the primary first sensor pointopenings configured to overlap parts of an electrode and the primarysecond sensor point openings configured to overlap parts of anotherelectrode different from the electrode at least partly overlapped by theprimary first sensor point openings.

The sensor point openings of the first adhesive layer may comprisesecondary sensor point openings. The secondary sensor point openings maycomprise one or more secondary first sensor point openings and one ormore secondary second sensor point openings, the secondary first sensorpoint openings configured to overlap parts of an electrode and thesecondary second sensor point openings configured to overlap parts ofanother electrode different from the electrode at least partlyoverlapped by the secondary first sensor point openings.

The sensor point openings of the first adhesive layer may comprisetertiary sensor point openings. The tertiary sensor point openings maycomprise one or more tertiary first sensor point openings and one ormore tertiary second sensor point openings, the tertiary first sensorpoint openings configured to overlap parts of an electrode and thetertiary second sensor point openings configured to overlap parts ofanother electrode different from the electrode at least partlyoverlapped by the tertiary first sensor point openings.

The first adhesive layer may have a substantially uniform thickness. Thefirst adhesive layer may have a thickness in the range from 0.1 mm to1.5 mm, e.g. in the range from 0.2 mm to 1.2 mm.

The first adhesive layer may have a primary thickness in a primary partof the first adhesive layer, e.g. in a primary region within a primaryradial distance or in a primary radial distance range from the centerpoint of the stomal opening. The primary thickness may be in the rangefrom 0.2 mm to 1.5 mm. such as about 1.0 mm. The primary radial distancemay be in the range from 20 mm to 50 mm, such as in the range from 25 mmto 35 mm, e.g. 30 mm.

The first adhesive layer may have a secondary thickness in a secondarypart of the first adhesive layer, e.g. in a secondary region outside asecondary radial distance or in a secondary radial distance range fromthe center point of the stomal opening. The secondary thickness may bein the range from 0.2 mm to 1.0 mm, such as about 0.5 mm. The secondaryradial distance may be in the range from 20 mm to 50 mm, such as in therange from 25 mm to 35 mm, e.g. 30 mm.

The base plate may comprise a second layer. The second layer may be anadhesive layer, also denoted rim adhesive layer. The second layer mayhave a second radial extension that is larger than a first radialextension of the first adhesive layer at least in a first angular rangeof the base plate. Accordingly, a part of a proximal surface of thesecond layer may be configured for attachment to the skin surface of auser. The part of a proximal surface of the second layer configured forattachment to the skin surface of a user is also denoted the skinattachment surface of the second adhesive layer. The second layer mayhave a stomal opening with a center point.

The second adhesive layer may be made of a second composition. Thesecond composition may comprise one or more polyisobutenes and/orstyrene-isoprene-styrene. The second composition may comprise one ormore hydrocoloids.

The second composition may be a pressure sensitive adhesive compositionsuitable for medical purposes comprising a rubbery elastomeric base andone or more water soluble or water swellable hydrocolloids. The secondcomposition may comprise one or more polybutenes, one or more styrenecopolymers, one or more hydrocolloids, or any combination thereof. Thecombination of the adhesive properties of the polybutenes and theabsorbing properties of the hydrocolloids renders the second compositionsuitable for use in ostomy appliances. The styrene copolymer may forexample be a styrene-butadiene-styrene block copolymer or astyrene-isoprene-styrene block copolymer. Preferably, one or morestyrene-isoprene-styrene (SIS) block type copolymers are employed. Theamount of styrene block-copolymer may be from 5% to 20% of the totaladhesive composition. The butene component is suitably a conjugatedbutadiene polymer selected from polybutadiene, polyisoprene. Thepolybutenes are preferably present in an amount of from 35-50% of thetotal adhesive composition. Preferably, the polybutene ispolyisobutylene (PIB). Suitable hydrocolloids for incorporation in thesecond composition are selected from naturally occurring hydrocolloids,semisynthetic hydrocolloids and synthetic hydrocolloids. The secondcomposition may comprise 20-60% hydrocolloids. A preferred hydrocolloidis carboxymethylcellulose (CMC). The second composition may optionallycontain other components, such as fillers, tackifiers, plasticizers, andother additives.

Different ratio of contents may change properties of the first and/orsecond adhesive layers. The second adhesive layer and the first adhesivelayer may have different properties. The second adhesive layer (secondcomposition) and the first adhesive layer (first composition) may havedifferent ratios of polyisobutenes, styrene-isoprene-styrene, and/orhydrocoloids. For example, the second adhesive layer may provide astronger attachment to the skin compared to attachment to the skinprovided by the first adhesive layer. Alternatively or additionally, thesecond adhesive layer may be thinner than the first adhesive layer.Alternatively or additionally, the second adhesive layer may be lesswater and/or sweat absorbing than the first adhesive layer.Alternatively or additionally, the second adhesive layer may be lessmouldable than the first adhesive layer. The second adhesive layer mayprovide a second barrier against leakage.

The second layer may have a substantially uniform thickness. The secondlayer may have a thickness in the range from 0.1 mm to 1.5 mm, e.g. inthe range from 0.2 mm to 1.0 mm, such as 0.5 mm, 0.6 mm, or 0.7 mm.

The base plate comprises one or more electrodes, such as a plurality ofelectrodes, such as two, three, four, five, six, seven or moreelectrodes. The electrodes, e.g. some or all the electrodes, may bearranged between the first adhesive layer and the second adhesive layer.The electrodes may be arranged in an electrode assembly, e.g. anelectrode layer. In embodiments, the electrode layer may be formed as awater sealing or a water transparent structure to allow water transportfrom the first adhesive layer to the second adhesive layer. An electrodecomprises a connection part for connecting the electrodes to othercomponents and/or interface terminals. An electrode may comprise one ormore conductor parts and/or one or more sensing parts. The electrodeassembly may be arranged between the first adhesive layer and the secondadhesive layer. The base plate, e.g. the electrode assembly, maycomprise a first electrode, a second electrode and optionally a thirdelectrode. The base plate, e.g. the electrode assembly, may comprise afourth electrode and/or a fifth electrode. The base plate, e.g. theelectrode assembly, optionally comprises a sixth electrode. The baseplate, e.g. the electrode assembly, may comprise a ground electrode. Theground electrode may comprise a first electrode part. The firstelectrode part of the ground electrode may form a ground for the firstelectrode. The ground electrode may comprise a second electrode part.The second electrode part of the ground electrode may form a ground forthe second electrode. The ground electrode may comprise a thirdelectrode part. The third electrode part of the ground electrode mayform a ground for the third electrode. The ground electrode may comprisea fourth electrode part. The fourth electrode part of the groundelectrode may form a ground for the fourth electrode and/or the fifthelectrode.

The ground electrode or electrode parts of the ground electrode may beconfigured as or form a (common) reference electrode for some or all ofthe other electrodes of the electrode assembly. The ground electrode mayalso be denoted reference electrode.

The electrodes are electrically conductive and may comprise one or moreof metallic (e.g. silver, copper, gold, titanium, aluminium, stainlesssteel), ceramic (e.g. ITO), polymeric (e.g. PEDOT, PANI, PPy), andcarbonaceous (e.g. carbon black, carbon nanotube, carbon fibre,graphene, graphite) materials.

Two electrodes of the electrode assembly may form a sensor. The firstelectrode and the ground electrode (e.g. first electrode part of theground electrode) may form a first sensor or first electrode pair. Thesecond electrode and the ground electrode (e.g. second electrode part ofthe ground electrode) may form a second sensor or second electrode pair.The third electrode and the ground electrode (e.g. third electrode partof the ground electrode) may form a third sensor or third electrodepair. The fourth electrode and the ground electrode (e.g. fourthelectrode part of the ground electrode) may form a fourth sensor orfourth electrode pair. The fifth electrode and the ground electrode(e.g. fifth electrode part of the ground electrode) may form a fifthsensor or fifth electrode pair.

The first electrode may form an open loop. The second electrode may forman open loop and/or the third electrode may form an open loop. Thefourth electrode may form an open loop. The fifth electrode may form anopen loop. Open loop electrode(s) enables electrode arrangement in fewor a single electrode layer.

The electrode assembly may comprise a support layer, also denoted asupport film. One or more electrodes may be formed, e.g. printed, on theproximal side of the support layer. One or more electrodes may beformed, e.g. printed, on the distal side of the support layer. Theelectrode assembly may have a stomal opening with a center point.

The support layer may comprise polymeric (e.g. polyurethane, PTFE, PVDF)and/or ceramic (e.g. alumina, silica) materials. In one or moreexemplary base plates, the support layer is made of thermoplasticpolyurethane (TPU). The support layer material may be made of orcomprise one or more of polyester, a thermoplastic elastomer (TPE),polyamide, polyimide, Ethylene-vinyl acetate (EVA), polyurea, andsilicones.

Exemplary thermoplastic elastomers of the support layer are styrenicblock copolymers (TPS, TPE-s), thermoplastic polyolefinelastomers (TPO,TPE-o), thermoplastic Vulcanizates (TPV, TPE-v), thermoplasticpolyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E), andthermoplastic polyamides (TPA, TPE-A).

The electrode assembly/base plate may comprise a masking elementconfigured to insulate at least parts of the electrodes from the firstadhesive layer of the base plate. The masking element may comprise oneor more, such as a plurality of, sensor point openings. The sensor pointopenings may comprise primary sensor point openings and/or secondarysensor point openings. The sensor point openings may comprise tertiarysensor point opening(s). The sensor point openings may comprisequaternary sensor point opening(s) A sensor point opening of the maskingelement overlaps at least one electrode of the electrode assembly whenseen in the axial direction, e.g. to form a sensor point. For example, aprimary sensor point opening may overlap a part of the ground electrodeand/or a part of the fourth electrode. A secondary sensor point openingmay overlap a part of the fourth electrode and/or a part of the fifthelectrode. A tertiary sensor point opening may overlap a part of thefifth electrode and/or a part of the ground electrode.

The masking element may comprise one or more, such as a plurality of,terminal openings. The masking element may comprise polymeric (e.g.polyurethane, PTFE, PVDF) and/or ceramic (e.g. alumina, silica)materials. In one or more exemplary base plates, the masking element ismade of or comprises thermoplastic polyurethane (TPU). In one or moreexemplary base plates, the masking element is made of or comprisespolyester. The masking element material may be made of or comprise oneor more of polyester, a thermoplastic elastomer (TPE), polyimide,polyimide, Ethylene-vinyl acetate (EVA), polyurea, and silicones.

Exemplary thermoplastic elastomers of the masking element are styrenicblock copolymers (TPS, TPE-s), thermoplastic polyolefinelastomers (TPO,TPE-o), thermoplastic Vulcanizates (TPV, TPE-v), thermoplasticpolyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E), andthermoplastic polyamides (TPA, TPE-A).

The base plate may comprise a first intermediate element. The firstintermediate element may be arranged between the electrodes/electrodelayer and the first adhesive layer and/or between the second layer andthe first adhesive layer. The first intermediate layer may be made of aninsulating material.

The base plate may comprise a release liner. The release liner is aprotective layer that protects adhesive layer(s) during transport andstorage and is peeled off by the user prior to applying the base plateon the skin. The release liner may have a stomal opening with a centerpoint.

The base plate may comprise a top layer. The top layer is a protectivelayer protecting the adhesive layer(s) from external strains and stresswhen the user wears the ostomy appliance. The electrodes, e.g. some orall the electrodes, may be arranged between the first adhesive layer andthe top layer. The top layer may have a stomal opening with a centerpoint. The top layer may have a thickness in the range from 0.01 mm to1.0 mm, e.g. in the range from 0.02 mm to 0.2 mm, such as 0.04 mm.

The base plate comprises a monitor interface. The monitor interface maybe configured for electrically and/or mechanically connecting the ostomyappliance (base plate) to the monitor device. The monitor interface maybe configured for wirelessly connecting the ostomy appliance (baseplate) to the monitor device. Thus, the monitor interface of the baseplate is configured to electrically and/or mechanically couple theostomy appliance and the monitor device.

The monitor interface of the base plate may comprise, e.g. as part of afirst connector of the monitor interface, a coupling part for forming amechanical connection, such as a releasable coupling between the monitordevice and the base plate. The coupling part may be configured to engagewith a coupling part of the monitor device for releasably coupling themonitor device to the base plate.

The monitor interface of the base plate may comprise, e.g. as part of afirst connector of the monitor interface, a plurality of terminals, suchas two, three, four, five, six, seven or more terminals, for formingelectrical connections with respective terminals of the monitor device.The monitor interface may comprise a ground terminal element forming aground terminal. The monitor interface may comprise a first terminalelement forming a first terminal, a second terminal element forming asecond terminal and optionally a third terminal element forming a thirdterminal. The monitor interface may comprise a fourth terminal elementforming a fourth terminal and/or a fifth terminal element forming afifth terminal. The monitor interface optionally comprises a sixthterminal element forming a sixth terminal. The terminal elements of themonitor interface may contact respective electrodes of the baseplate/electrode assembly. The first intermediate element may be arrangedbetween the terminal elements and the first adhesive layer. The firstintermediate element may cover or overlap terminal element(s) of thebase plate when seen in the axial direction. Thus, the first adhesivelayer may be protected or experience more evenly distributed mechanicalstress from the terminal elements of the base plate, in turn reducingthe risk of terminal elements penetrating or otherwise damaging thefirst adhesive layer. The first intermediate element may protect ormechanically and/or electrically shield the first adhesive layer fromthe terminal elements of the base plate.

The base plate may comprise a coupling ring or other coupling member forcoupling an ostomy pouch to the base plate (two-part ostomy appliance).The center point may be defined as a center of the coupling ring.

The base plate has a stomal opening with a center point. The size and/orshape of the stomal opening is typically adjusted by the user or nursebefore application of the ostomy appliance to accommodate the user'sstoma. In one or more exemplary base plates, the user forms the stomalopening during preparation of the base plate for application.

The monitor device comprises a processor and one or more interfaces,such as a first interface and/or a second interface. The monitor devicemay comprise a memory for storing ostomy data.

In one or more exemplary monitor devices, the processor is configured toapply a processing scheme, the first interface is connected to theprocessor and the memory, and the first interface is configured forcollecting ostomy data from the base plate coupled to the firstinterface. The ostomy data may comprise one or more, such as all, offirst ostomy data from a first electrode pair of the base plate, secondostomy data from a second electrode pair of the base plate, and thirdostomy data from a third electrode pair of the base plate. A secondinterface is connected to the processor. To apply a processing schememay comprise one or more of obtain first parameter data based on thefirst ostomy data; obtain second parameter data based on the secondostomy data; and obtain third parameter data based on the third ostomydata. To apply a processing scheme may comprise determine an operatingstate of the base plate of the ostomy appliance based on one or more,such as all, of the first parameter data, the second parameter data andthe third parameter data. The operating state may be indicative of adegree of radial erosion of the base plate, such as of the firstadhesive layer, and/or an acute leakage risk for the ostomy appliance.The monitor device is configured to, in accordance with a determinationthat the operating state is a first operating state, transmit a firstmonitor signal comprising monitor data indicative of the first operatingstate of the base plate via the second interface; and/or in accordancewith a determination that the operating state is a second operatingstate, transmit a second monitor signal comprising monitor dataindicative of the second operating state of the base plate via thesecond interface.

In one or more exemplary monitor devices, the first operating state ofthe base plate corresponds to a situation wherein the first adhesivelayer of the base plate has experienced a first degree of radialerosion, e.g. the first adhesive layer is eroded to a first radialdistance of the first electrode pair but not to a second radial distanceof the second electrode pair.

In one or more exemplary monitor devices, the second operating state ofthe base plate corresponds to a situation wherein the first adhesivelayer of the base plate has experienced a second degree of radialerosion, e.g. the first adhesive layer is eroded to the second radialdistance of the second electrode pair but not to a third radial distanceof the third electrode pair.

To obtain first parameter data based on the first ostomy data maycomprise determining one or more first parameters based on the firstostomy data. To obtain second parameter data based on the second ostomydata may comprise determining one or more second parameters based on thesecond ostomy data. To obtain third parameter data based on the thirdostomy data may comprise determining one or more third parameters basedon the third ostomy data. In one or more exemplary monitor devices,determination of an operating state may be based on one or more firstparameters, such as first primary parameter and/or first secondaryparameter of first parameter data. In one or more exemplary monitordevices, determination of an operating state may be based on one or moresecond parameters, such as second primary parameter and/or secondsecondary parameter of the second parameter data. In one or moreexemplary monitor devices, determination of an operating state may bebased on one or more third parameters, such as third primary parameterand/or third secondary parameter of the third parameter data. In one ormore exemplary monitor devices, determination of an operating state maybe based on one or more fourth parameters, such as fourth primaryparameter and/or fourth secondary parameter of the fourth parameterdata.

The first parameter data, the second parameter data, and the thirdparameter data may be indicative of resistance between the firstelectrode pair, the second electrode pair, and the third electrode pair,respectively.

The first parameter data, the second parameter data, and the thirdparameter data may be indicative of a rate of change in resistancebetween the first electrode pair, the second electrode pair, and thethird electrode pair, respectively.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a first criteria set based on thefirst parameter data and/or the second parameter data, wherein theoperating state is determined to be the first operating state if thefirst criteria set is satisfied. The first criteria set may comprise oneor more first criteria based on one or more of first parameter data,second parameter data and third parameter data. The first criteria setmay comprise a first primary criterion based on the first parameterdata. The first criteria set may comprise a first secondary criterionbased on the second parameter data. The first criteria set may comprisea first tertiary criterion based on the third parameter data.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate may be based on a first threshold set comprisingone or a plurality of first threshold values. The first threshold setmay comprise one or a plurality of threshold values, e.g. to be appliedin the first criteria set. The first threshold set may comprise a firstprimary threshold value. The first threshold set may comprise a firstsecondary threshold value. The first threshold set may comprise a firsttertiary threshold value.

The first criteria set may be given by

-   -   (P_1_1<TH_1_1),    -   (P_2_1>TH_1_2), and    -   (P_3_1>TH_1_3),

wherein P_1_1 is a first primary parameter based on the first parameterdata, TH_1_1 is a first primary threshold value, P_2_1 is a secondprimary parameter based on the second parameter data, TH_1_2 is a firstsecondary threshold value, P_3_1 is a third primary parameter based onthe third parameter data, and TH_1_3 is a first tertiary thresholdvalue, and wherein the first operating state is indicative of low degreeof radial erosion on the base plate. The first threshold values (TH_1_1,TH_1_2 and TH_1_3) may be the same or different, e.g. depending on theelectrode configuration of the base plate. The first tertiary criterion(P_3_1<TH_1_3) may be omitted in the first criteria set.

The first primary parameter P_1_1 may be indicative of the resistancebetween the first electrode pair (first electrode and first electrodepart of the ground electrode) of the base plate.

The second primary parameter may be indicative of the resistance betweenthe second electrode pair (second electrode and second electrode part ofthe ground electrode) of the base plate.

The third primary parameter may be indicative of resistance between thethird electrode pair (third electrode and third electrode part of theground electrode) of the base plate.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a second criteria set based on thesecond parameter data and/or the third parameter data, wherein theoperating state is determined to be the second operating state if thesecond criteria set is satisfied. The second criteria set may be basedon the first parameter data.

The second criteria set may comprise one or more second criteria basedon one or more of first parameter data, second parameter data and thirdparameter data. The second criteria set may comprise a second primarycriterion based on the first parameter data. The second criteria set maycomprise a second secondary criterion based on the second parameterdata. The second criteria set may comprise a second tertiary criterionbased on the third parameter data.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a second threshold set comprisingone or a plurality of second threshold values. The second threshold setmay comprise one or a plurality of threshold values, e.g. to be appliedin the second criteria set. The second threshold set may comprise asecond primary threshold value. The second threshold set may comprise asecond secondary threshold value. The second threshold set may comprisea second tertiary threshold value.

The second criteria set may be given by

-   -   (P_1_1<TH_2_1),    -   (P_2_1<TH_2_2), and    -   (P_3_1>TH_2_3)

wherein P_1_1 is a first primary parameter based on the first parameterdata and indicative of the resistance between the first electrode pair,TH_2_1 is a second primary threshold value, P_2_1 is a second primaryparameter based on the second parameter data and indicative of theresistance between the second electrode pair, TH_2_2 is a secondsecondary threshold value, P_3_1 is a third primary parameter based onthe third parameter data and indicative of the resistance between thethird electrode pair, TH_2_3 is a second tertiary threshold value, andwherein the second operating state is indicative of medium degree ofradial erosion on the base plate. The second threshold values (TH_2_1,TH_2_2 and TH_2_3) may be the same or different, e.g. depending on theelectrode configuration of the base plate. The second primary criterion(P_1_1<TH_2_1) and/or the second tertiary criterion (P_3_1>TH_2_3) maybe omitted in the second criteria set.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a default criteria set based on thefirst parameter data, wherein the operating state is determined to bethe default operating state if the default criteria set is satisfied,and in accordance with a determination that the operating state is thedefault operating state, transmit a default monitor signal comprisingmonitor data indicative of the default operating state of the ostomyappliance.

The default criteria set may be given by

-   -   (P_1_1>TH_D_1),    -   (P_2_1>TH_D_2), and    -   (P_3_1>TH_D_3)

wherein P_1_1 is a first primary parameter based on the first parameterdata and indicative of the resistance between the first electrode pair,TH_D_1 is a default primary threshold value, P_2_1 is a second primaryparameter based on the second parameter data and indicative of theresistance between the second electrode pair, TH_D_2 is a defaultsecondary threshold value, P_3_1 is a third primary parameter based onthe third parameter data and indicative of the resistance between thethird electrode pair, TH_D_3 is a default tertiary threshold value, andwherein the default operating state is indicative of very low or nodegree of radial erosion on the base plate. The default threshold values(TH_D_1, TH_D_2 and TH_D_3) may be the same or different, e.g. dependingon the electrode configuration of the base plate.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a third criteria set based on thethird parameter data, wherein the operating state is determined to bethe third operating state if the third criteria set is satisfied, and inaccordance with a determination that the operating state is the thirdoperating state, transmit a third monitor signal comprising monitor dataindicative of the third operating state of the ostomy appliance.

In one or more exemplary monitor devices, the third operating state ofthe base plate corresponds to a situation wherein the first adhesivelayer of the base plate has experienced a third degree of radialerosion, e.g. the first adhesive layer is eroded to the third radialdistance of the third electrode pair.

The third criteria set may be given by

-   -   (P_1_1<TH_3_1),    -   (P_2_1<TH_3_2), and    -   (P_3_1<TH_3_3)

wherein P_1_1 is a first primary parameter based on the first parameterdata and indicative of the resistance between the first electrode pair,TH_3_1 is a third primary threshold value, P_2_1 is a second primaryparameter based on the second parameter data and indicative of theresistance between the second electrode pair, TH_3_2 is a thirdsecondary threshold value, P_3_1 is a third primary parameter based onthe third parameter data and indicative of the resistance between thethird electrode pair, TH_3_3 is a third tertiary threshold value, andwherein the third operating state is indicative of high degree of radialerosion on the base plate. The third threshold values (TH_3_1, TH_3_2and TH_3_3) may be the same or different, e.g. depending on theelectrode configuration of the base plate. The third primary criterion(P_1_1<TH_3_1) and/or the third secondary criterion (P_2_1<TH_3_2) maybe omitted in the third criteria set.

In one or more exemplary monitor devices, the ostomy data comprisesfourth ostomy data from a fourth electrode pair of the base plate. Toapply a processing scheme may comprise to obtain fourth parameter databased on the fourth ostomy data, and determine an operating state of thebase plate of the ostomy appliance based on the fourth parameter data.The monitor device may be configured to, in accordance with adetermination that the operating state is a fourth operating state,transmit a fourth monitor signal comprising monitor data indicative ofthe fourth operating state of the ostomy appliance.

In one or more exemplary monitor devices, the fourth operating state ofthe base plate corresponds to a situation, wherein the fourth electrodepair detects fluid, such as output, between the distal surface of firstadhesive layer and the skin of the user at a fourth radial distance, andthus there is a high risk of leakage from the ostomy appliance in thefourth operating state.

The fourth criteria set may be given by

-   -   (P_4_1<TH_4_4)

wherein P_4_1 is a fourth primary parameter based on the fourthparameter data and indicative of the resistance between the fourthelectrode pair and TH_4_4 is a fourth quaternary threshold value, andwherein the fourth operating state is indicative of high risk of leakagefrom the ostomy appliance.

The monitor device comprises a monitor device housing optionally made ofa plastic material. The monitor device housing may be an elongatehousing having a first end and a second end. The monitor device housingmay have a length or maximum extension along a longitudinal axis in therange from 1 cm to 15 cm. The monitor device housing may have a width ormaximum extension perpendicular to the longitudinal axis in the rangefrom 0.5 cm to 3 cm. The monitor device housing may be curve-shaped.Additionally or alternatively, the monitor device housing may be rigidor flexible.

The monitor device comprises a first interface. The first interface maybe configured as an appliance interface for electrically and/ormechanically connecting the monitor device to the ostomy appliance.Thus, the appliance interface is configured to electrically and/ormechanically couple the monitor device and the ostomy appliance. Thefirst interface may be configured as an accessory device interface forelectrically and//or mechanically connecting the monitor device to anaccessory device, such as a docking station. The first interface may beconfigured for coupling to a docking station of the ostomy system, e.g.for charging the monitor device and/or for data transfer between themonitor device and the docking station.

The first interface of the monitor device may comprise a plurality ofterminals, such as two, three, four, five, six, seven or more terminals,for forming electrical connections with respective terminals and/orelectrodes of the ostomy appliance. One or more terminals of the firstinterface may be configured for forming electrical connections with anaccessory device, e.g. with respective terminals of a docking station.The first interface may comprise a ground terminal. The first interfacemay comprise a first terminal, a second terminal and optionally a thirdterminal. The first interface may comprise a fourth terminal and/or afifth terminal. The first interface optionally comprises a sixthterminal. In one or more exemplary monitor devices, the first interfacehas M terminals, wherein M is an integer in the range from 4 to 8.

The first interface of the monitor device may comprise a coupling partfor forming a mechanical connection, such as a releasable couplingbetween the monitor device and the base plate. The coupling part and theterminals of the first interface form (at least part of) a firstconnector of the monitor device.

The monitor device comprises a power unit for powering the monitordevice. The power unit may comprise a battery. The power unit maycomprise charging circuitry connected to the battery and terminals ofthe first interface for charging the battery via the first interface,e.g. the first connector. The first interface may comprise separatecharging terminal(s) for charging the battery. Additionally oralternatively, the sensor terminal may change its function if thecharging voltage is sensed at relevant terminals.

The monitor device may comprise a sensor unit with one or more sensor.The sensor unit is connected to the processor for feeding sensor data tothe processor. The sensor unit may comprise an accelerometer for sensingacceleration and provision of acceleration data to the processor. Thesensor unit may comprise a temperature sensor for provision oftemperature data to the processor.

The monitor device comprises a second interface connected to theprocessor. The second interface may be configured as an accessoryinterface for connecting, e.g. wirelessly connecting, the monitor deviceto one or more accessory devices. The second interface may comprise anantenna and a wireless transceiver, e.g. configured for wirelesscommunication at frequencies in the range from 2.4 to 2.5 GHz. Thewireless transceiver may be a Bluetooth transceiver, i.e. the wirelesstransceiver may be configured for wireless communication according toBluetooth protocol, e.g. Bluetooth Low Energy, Bluetooth 4.0, Bluetooth5. The second interface optionally comprises a loudspeaker and/or ahaptic feedback element for provision of an audio signal and/or hapticfeedback to the user, respectively.

In one or more exemplary ostomy systems, the monitor device forms anintegrated part of the ostomy appliance, e.g. the monitor device mayform an integrated part of a base plate of the ostomy appliance.

The ostomy system may comprise a docking station forming an accessorydevice of the ostomy system. The docking station may be configured toelectrically and/or mechanically couple the monitor device to thedocking station.

The docking station may comprise a docking monitor interface. Thedocking monitor interface may be configured for electrically and/ormechanically connecting the monitor device to the docking station. Thedocking monitor interface may be configured for wirelessly connectingthe monitor device to the docking station. The docking monitor interfaceof the docking station may be configured to electrically and/ormechanically couple the docking station and the monitor device.

The docking monitor interface of the docking station may comprise, e.g.as part of a first connector of the docking monitor interface, acoupling part for forming a mechanical connection, such as a releasablecoupling between the monitor device and the docking station. Thecoupling part may be configured to engage with a coupling part of themonitor device for releasably coupling the monitor device to the dockingstation.

The docking monitor interface of the docking station may comprise, e.g.as part of a first connector of the docking monitor interface, aplurality of terminals, such as two, three, four, five, six, seven ormore terminals, for forming electrical connections with respectiveterminals of the monitor device. The docking monitor interface maycomprise a ground terminal. The docking monitor interface may comprise afirst terminal and/or a second terminal. The docking station maycomprise a third terminal. The docking monitor interface may comprise afourth terminal and/or a fifth terminal. The docking monitor interfaceoptionally comprises a sixth terminal.

Disclosed is a base plate of an ostomy appliance. The base platecomprises a first adhesive layer including: a stomal opening with acenter point and a proximal surface configured to be attached to a skinsurface of a user. In embodiments, the base plate may comprise a maskingelement arranged on a distal surface of the first adhesive layer,wherein the masking element may be more insulative than the firstadhesive layer. Additionally or alternatively, the base plate maycomprise a plurality of electrodes arranged on a distal side of thefirst adhesive layer, wherein each electrode includes a sensing part anda conductor part, wherein the masking element may be arranged betweenthe conductor parts and the first adhesive layer.

In embodiments, the sensing parts of each electrode may facilitatedetermining a leak between a skin surface of the user and the base plateand/or the state of the adhesive device. Additionally or alternatively,by including a masking element arranged between the conductor parts andthe first adhesive layer, the conductor parts of the electrodes may beinsulated from the first adhesive layer, which may prevent more than oneof the conductor parts of the electrodes from shorting together due tomoisture absorption of the first adhesive layer.

The plurality of electrodes may be formed on a proximal surface of asupport layer. The support layer may increase the structural integrityof the electrodes to, perhaps, reduce the likelihood the electrodes aredamaged and/or broken.

The plurality of electrodes may be printed on the support layer.

The plurality of electrodes may form a first resistive pair ofelectrodes and a second resistive pair of electrodes, wherein eachresistive pair of electrodes may include an electrode part of a groundelectrode. The first and second resistive pairs of the electrodes mayfacilitate determining the adhesion between the base plate and the skinsurface of a user. By determining the adhesion between the base plateand the skin surface of a user, the user may be alerted if the adhesionis deteriorating.

The moisture content of a respective sensing zone may be indicative ofhow well the first adhesive layer is adhering to the skin surface of auser. To determine the moisture content of a respective sensing zone, aresistance between the electrodes included in the first, second, and/orthird resistive pairs may be sensed by, for example, the monitor device.And, when the resistance between the electrodes included in the first,second, and/or third resistive pairs decreases below a threshold level,the monitor device may send an indication to the user that the adhesionbetween the first adhesive layer and the skin surface of a user may bedeteriorating. In embodiments, when the adhesion between the firstadhesive layer and the skin surface of a user proximal to the thirdresistive pair deteriorates, the monitor device may send a signal to theuser suggesting the user change his/her ostomy appliance and/or baseplate. Additionally or alternatively, when the adhesion between thefirst adhesive layer and the skin surface of a user proximal to thefirst resistive pair and/or second resistive pair deteriorates, themonitor device may send a signal to the user suggesting the user changehis/her ostomy appliance and/or base plate.

In embodiments, the second resistive pair of electrodes may at leastpartially surround the first resistive pair of electrodes. By includinga second resistive pair that at least partially surrounds a firstresistive pair, a velocity of the deterioration of adhesion between thebase plate and the skin surface of a user may be determined.

The plurality of electrodes may form a third resistive pair ofelectrodes, wherein the third resistive pair of electrodes includes anelectrode part of a ground electrode.

The third resistive pair of electrodes may at least partially surroundthe second resistive pair of electrodes. By including a third resistivepair that at least partially surrounds the second resistive pair ofelectrodes, and determining a velocity of adhesion deterioration basedon the first and second resistive pairs, a prediction may be made as towhen the adhesion between the skin surface of a user and the base plateproximal to the third resistive pair may deteriorate.

By including different resistive pairs which at least partially surroundone another, a monitor device may determine how quickly the adhesionbetween the first adhesive layer and the skin surface of a user may bedeteriorating. For example, a monitor device may determine that at timet₁ the adhesion between the first adhesive layer and the skin surface ofa user proximal to the first resistive pair is deteriorating by sensinga reduced resistance between the electrodes included in the firstresistive pair. Then, at time t₂ the monitor device may determine theadhesion between the first adhesive layer and the skin surface of a userproximal to the second resistive pair is deteriorating by sensing areduced resistance between the electrodes included in the secondresistive pair. By knowing how the distance between the first and secondresistive pairs, the monitor device 6 may be calculate a velocity bydividing the distance between the first and second resistive pairs bythe difference between t₁ and t₂. The computed velocity may thendetermine how much time a user has before the adhesion between the firstadhesive layer and the skin surface of a user proximal to the thirdresistive pair deteriorates, which may be when the user would like tochange his/her ostomy appliance and/or base plate.

In embodiments, at least one of the first resistive pair, the secondresistive pair, and the third resistive pair may be arrangedcircumferentially around the center point the stomal opening of the baseplate.

The base plate may comprise a first intermediate element, wherein thefirst intermediate element may be less compliant than the first adhesivelayer, wherein each electrode may include a connection part and whereinthe first intermediate element may be arranged between the connectionparts and the first adhesive layer. By including the first intermediateelement, the connection parts of the electrodes may be less likely to bedamaged and/or broken.

In embodiments, the first intermediate element may facilitate protectingthe terminal elements and/or the connection parts. For example, thefirst intermediate element may be less compliant than the first adhesivelayer, the second adhesive layer, and/or the masking element. By beingless compliant, the first intermediate element may reduce the ability ofthe terminal elements and/or the connection parts to flex. As such, theterminal elements and/or the connection parts may be less likely tobreak due to flexure. In embodiments, the first intermediate element maycomprise at least one of polymeric (e.g. polyurethane, PTFE, PVDF) andceramic (e.g. alumina, silica) materials.

Additionally or alternatively, the first intermediate element may reducethe likelihood that more than one of the terminal elements are shortedtogether and/or more than one of the connection parts are shortedtogether. For example, the first intermediate element may be lessmoisture absorbent than the first adhesive layer and/or the maskingelement. By being less moisture absorbent, the first intermediateelement may prevent moisture (e.g., sweat, output, etc.) from cominginto contact with one or more of the terminal elements and/or theconnection parts via the first adhesive layer and/or the masking elementand, potentially, shorting a combination of the terminal elementstogether and/or a combination of the connection parts together.

In embodiments, each electrode may include a connection part, whereinthe masking element may comprise a plurality of terminal openings, andwherein each terminal opening may overlap a connection part.

In embodiments, wherein the first adhesive layer, au comprises aplurality of openings, wherein the masking element comprises a pluralityof openings, and wherein each opening of the plurality of openings ofthe first adhesive layer overlaps an opening of the plurality ofopenings of the masking element for form a sensor point. In embodiments,the sensor points may be used to detect a leakage between a skin surfaceof a user and the base plate.

In embodiments, the sensor points may be generally equal distances fromthe center point.

The base plate may further comprise a second adhesive layer arrangeddistally of the plurality of electrodes. The second adhesive layer mayprotect the electrodes and/or add structural integrity to the baseplate.

In embodiments, the first adhesive layer and the second adhesive layermay be comprised of different ratios of one or more of: polyisobutenes,styrene-isoprene-styrene, and/or hydrocoloids. By being comprised ofdifferent ratios of materials, the second adhesive layer may provide astronger attachment to the skin compared to attachment to the skinprovided by the first adhesive layer and/or the first adhesive layer mayprovide less irritation to the skin surface of a user.

FIG. 1 illustrates an exemplary ostomy system. The ostomy system 1comprises an ostomy appliance 2 including a base plate 4 and an ostomypouch (not shown). Further, the ostomy system 1 comprises a monitordevice 6 and an accessory device 8 (mobile telephone). The monitordevice 6 is connectable to the base plate 4 via respective firstconnectors of the monitor device 6 and base plate 4. The monitor device6 is configured for wireless communication with the accessory device 8.Optionally, the accessory device 8 is configured to communicate with aserver device 10 of the ostomy system 1, e.g. via network 12. The serverdevice 10 may be operated and/or controlled by the ostomy appliancemanufacturer, the accessory device 8, and/or a service centre. Ostomydata or parameter data based on the ostomy data are obtained fromelectrodes/sensors of the ostomy appliance 2 with the monitor device 6.The monitor device 6 processes the ostomy data and/or parameter databased on the ostomy data to determine monitor data that are transmittedto the accessory device 8. In the illustrated ostomy system, theaccessory device 8 is a mobile phone, however the accessory device 8 maybe embodied as another handheld device, such as a tablet device, or awearable, such as a watch or other wrist-worn electronic device.Accordingly, the monitor device 6 is configured to determine andtransmit monitor data to the accessory device 8. The base plate 4comprises a coupling member 14 in the form of a coupling ring 16 forcoupling an ostomy pouch (not shown) to the base plate (two-part ostomyappliance). In alternative embodiments, the ostomy pouch may be formedtogether with the base plate (one-part ostomy appliance).The base platehas a stomal opening 18 with a center point. The size and/or shape ofthe stomal opening 18 is typically adjusted by the user or nurse beforeapplication of the ostomy appliance to accommodate the user's stoma.

The ostomy system 1 optionally comprises a docking station 20 forming anaccessory device of the ostomy system 1. The docking station comprises20 comprises a docking monitor interface including a first connector 22configured for electrically and/or mechanically connecting the monitordevice 6 to the docking station 20. The docking monitor interface may beconfigured for wirelessly connecting the monitor device to the dockingstation. The docking station 20 comprises a user interface 24 forreceiving user input and/or providing feedback to the user on theoperational state of the docking station 20. The user interface 24 maycomprise a touch-screen. The user interface 24 may comprise one or morephysical buttons and/or one or more visual indicators, such as lightemitting diodes,

FIG. 2 is a schematic block diagram of an exemplary monitor device. Themonitor device 6 comprises a monitor device housing 100, a processor 101and one or more interfaces, the one or more interfaces including a firstinterface 102 (appliance interface) and a second interface 104(accessory interface). The monitor device 6 comprises a memory 106 forstoring ostomy data and/or parameter data based on the ostomy data. Thememory 106 is connected to the processor 101 and/or the first interface102.

The first interface 102 is configured as an appliance interface forelectrically and/or mechanically connecting the monitor device 6 to theostomy appliance, e.g. ostomy appliance 2. The first interface 102comprises a plurality of terminals for forming electrical connectionswith respective terminals of the ostomy appliance 2 (base plate 4). Inembodiments, the first interface 102 comprises a ground terminal 108, afirst terminal 110, a second terminal 112 and a third terminal 114. Thefirst interface 102 may also comprise a fourth terminal 116 and a fifthterminal 118. The first interface 102 of the monitor device 6 comprisesa coupling part 120 for forming a mechanical connection, such as areleasable coupling between the monitor device and the base plate. Thecoupling part 120 and the terminals 108, 110, 112, 114, 116, and 118 ofthe first interface 102 form (at least part of) a first connector of themonitor device 6.

The monitor device 6 comprises a power unit 121 for powering the monitordevice and active components thereof, i.e. the power unit 121 isconnected to the processor 101, the first interface 102, the secondinterface 104, and memory 106. The power unit comprises a battery andcharging circuitry. The charging circuitry is connected to the batteryand terminals of the first interface 102 for charging the battery viaterminals of the first interface, e.g. terminals of the first connector.

The second interface 104 of monitor device is configured as an accessoryinterface for connecting the monitor device 6 to one or more accessorydevices such as accessory device 8. The second interface 104 comprisesan antenna 122 and a wireless transceiver 124 configured for wirelesscommunication with accessory device(s). Optionally, the second interface104 comprises a loudspeaker 126 and/or a haptic feedback element 128 forprovision of respective audio signal and/or haptic feedback to the user.

The monitor device 6 comprises a sensor unit 140 connected to theprocessor 101. The sensor unit 140 comprises a temperature sensor forfeeding temperature data to the processor and a G-sensor oraccelerometer for feeding acceleration data to the processor 101.Additionally or alternatively, the sensor unit 140 comprises a humiditysensor and/or an acoustic sensor.

The processor 101 is configured to apply a processing scheme, and thefirst interface 102 is configured for collecting ostomy data from thebase plate coupled to the first interface, the ostomy data comprisingfirst ostomy data from a first electrode pair of the base plate, secondostomy data from a second electrode pair of the base plate, and thirdostomy data from a third electrode pair of the base plate. The ostomydata may be stored in the memory 106 and/or processed in the processor101 in order to obtain parameter data. The parameter data may be storedin the memory 106. The processor 101 is configured to apply a processingscheme, wherein to apply a processing scheme comprises obtain firstparameter data based on the first ostomy data; obtain second parameterdata based on the second ostomy data; obtain third parameter data basedon the third ostomy data. In other words, the processor 101 isconfigured to obtain first, second and third parameter data based onrespective first, second and third ostomy data. To apply a processingscheme comprises to determine an operating state of the base plate ofthe ostomy appliance based on one or more, e.g. all, of the firstparameter data, the second parameter data and the third parameter data,wherein the operating state is indicative of a degree of radial erosionof the base plate and/or acute leakage risk for the ostomy appliance.The monitor device 6 is configured to, in accordance with adetermination that the operating state is a first operating state,transmit a first monitor signal comprising monitor data indicative ofthe first operating state of the base plate via the second interface;and in accordance with a determination that the operating state is asecond operating state, transmit a second monitor signal comprisingmonitor data indicative of the second operating state of the base platevia the second interface.

FIG. 3 illustrates an exploded view of an exemplary base plate of anostomy appliance. The base plate 4 comprises a first adhesive layer 200.In embodiments, the first adhesive layer 200 comprises a stomal opening18A, which may be form part of the stomal opening 18. As stated above,the stomal opening 18 may be adjusted before application to accommodatethe user's stoma, which includes adjusting the stomal opening 18A.During use, the stoma-receiving opening 18, including the stomalopening18A, is arranged around a user's stoma and a proximal surface200B of the first adhesive layer 200 adheres to the skin surface of theuser in the peristomal area and/or to additional seals, such as sealingpaste, sealing tape and/or sealing ring.

In embodiments, the base plate 4 comprises a second adhesive layer 202,also denoted rim adhesive layer. As illustrated, the second adhesivelayer 202 may be arranged distally of the first adhesive layer 200.Additionally or alternatively, a portion of the distal surface 200A ofthe first adhesive layer 200, which is not covered by the electrodeassembly 204, may adhere to a portion of the proximal surface 202B ofthe second adhesive layer 202. In embodiments, the second adhesive layer202 may have a second radial extension that is larger than a firstradial extension of the first adhesive layer 200 at least in a firstangular range of the base plate 4.

The first adhesive layer 200 and/or second adhesive layer 202 maycomprise one or more of polyisobutenes, styrene-isoprene-styrene, and/orhydrocoloids. Different ratio of contents may change properties of thefirst and/or second adhesive layers 200, 202. As such, the secondadhesive layer 202 and the first adhesive layer 200 may have differentproperties due to different ratios of polyisobutenes,styrene-isoprene-styrene, and/or hydrocoloids. For example, the secondadhesive layer 202 may provide a stronger attachment to the skincompared to attachment to the skin provided by the first adhesive layer200. Additionally or alternatively, the first adhesive layer may provideless irritation to the skin surface of a user. In embodiments, thesecond adhesive layer 202 may be thinner than the first adhesive layer200. Additionally or alternatively, the second adhesive layer 202 may beless water and/or sweat absorbing than the first adhesive layer 200.Additionally or alternatively, the second adhesive layer 202 may be lessmouldable than the first adhesive layer 200. The second adhesive layer202 may provide a second barrier against leakage.

The base plate 4 comprises a plurality of electrodes arranged in anelectrode assembly 204. The electrode assembly 204 is arranged betweenthe first adhesive layer 200 and the second adhesive layer 202. Forexample, the electrode assembly 204 may be arranged on a distal side(e.g., the distal surface 200A) of the first resistive layer 200 and aproximal side (e.g., the proximal surface 202B) of the second resistivelayer 202,

The base plate 4 comprises a release liner 206 that is peeled off by theuser prior to applying the base plate 4 on the skin. The base plate 4comprises a top layer 208 and a coupling ring 209 for coupling an ostomypouch to the base plate 4. The top layer 208 is a protective layerprotecting the second adhesive layer 202 from external strains andstress during use.

The base plate 4 comprises a monitor interface. The monitor interface isconfigured for electrically and/or mechanically connecting the ostomyappliance (base plate 4) to the monitor device. The monitor interface ofthe base plate comprises a coupling part 210 for forming a mechanicalconnection, such as a releasable coupling between the monitor device andthe base plate. The coupling part 210 is configured to engage with acoupling part of the monitor device for releasably coupling the monitordevice to the base plate 4. Further, the monitor interface of the baseplate 4 comprises a plurality of terminal elements respectively forminga plurality of terminals 212 for forming electrical connections withrespective terminals of the monitor device. The coupling part 210 andthe terminals 212 form a first connector 211 of the base plate 4. Thebase plate 4 comprises a first intermediate element 213 on the distalside of the electrode assembly. The first intermediate element 213 isarranged between the terminal elements forming terminals 212 and thefirst adhesive layer (not shown). The first intermediate element 213covers the terminal elements forming terminals 212 of the base plate 4when seen in the axial direction and protects the first adhesive layerfrom mechanical stress from the terminal elements of the base plate.

FIG. 4 illustrates an exploded view of an exemplary electrode assembly204 of a base plate. The electrode assembly 204 comprises a supportlayer 214 with proximal surface 214B and electrodes 216 arranged on theproximal side of the support layer 214. The electrode assembly 204includes a ground electrode, a first electrode, a second electrode, athird electrode, a fourth electrode, and a fifth electrode, wherein eachelectrode has a respective connection part for connecting the electrodesto respective terminal elements of the monitor interface. Inembodiments, the electrodes 216 are electrically conductive and compriseat least one of metallic (e.g. silver, copper, gold, titanium,aluminium, stainless steel), ceramic (e.g. ITO), polymeric (e.g. PEDOT,PANI, PPy), and carbonaceous (e.g. carbon black, carbon nanotube, carbonfibre, graphene, graphite) materials. Additionally or alternatively, theelectrodes 216 may be screen-printing, inkjet-printing,direct-ink-writing, pen-plotting, 3D-printing,fused-deposition-modelling, contact-transfer printing, spray painting,chemical vapour depositing, physical vapour depositing,atomic-layer-depositing, wire-bending, and any other methods known to aperson skilled in the art. In embodiments, the electrodes 216 canrequire one of heat-curing, UV-curing, and oxygen-activating.

In embodiments, the support layer 214 may increase the structuralintegrity of the electrodes 216. Additionally or alternatively, thesupport layer 214 may be moisture resistance or moisture transmissive.In embodiments, the support layer 214 may comprise at least one ofpolymeric (e.g. polyurethane, PTFE, PVDF) and ceramic (e.g. alumina,silica) materials.

Further, electrode assembly 204 comprises a masking element 218 withproximal surface 218B. In embodiments, the masking element 218 may bearranged on the distal surface 200A of the first adhesive layer 200.Additionally or alternatively, the masking element 218 may be comprisedof a material that is more insulative (e.g., less electricallyconductive and/or less moisture-permeable) than the first adhesive layer200. In embodiments, the masking element 218 may comprise at least oneof polymeric (e.g. polyurethane, PTFE, PVDF) and ceramic (e.g. alumina,silica) materials. In embodiments, the masking element 218 may cover oroverlap with parts of the electrodes 216 when seen in the axialdirection. As such, the masking layer 218 may at least partiallyinsulate electrode parts of the electrodes 216 from the first adhesivelayer of the base plate 200.

FIG. 5 is a proximal view of proximal surfaces of base plate parts ofthe base plate 4 without the first adhesive layer 200 (illustrated inFIG. 4 ) and the release liner 206 (illustrated in FIG. 3 ). The baseplate 4 comprises a first intermediate element 213 on the distal side ofthe electrode assembly, i.e. between the electrode assembly 204 and thefirst adhesive layer. The first intermediate element 213 covers theterminal elements of the base plate 4 when seen in the axial directionand protects the first adhesive layer 200 from mechanical stress fromthe terminal elements of the base plate 4.

In embodiments, the first intermediate element 213 may facilitateprotecting the terminal elements 212 and/or the connection parts 222A,224A, 226A, 228A, 230A, 232A (see FIG. 6 ). For example, the firstintermediate element 213 may be less compliant than the first adhesivelayer 200 (depicted in FIG. 3 ), the second adhesive layer 202, and/orthe masking element 218. By being less compliant, the first intermediateelement 213 may reduce the ability of the terminal elements 212 and/orthe connection parts 222A, 224A, 226A, 228A, 230A, 232A to flex. Assuch, the terminal elements 212 and/or the connection parts 222A, 224A,226A, 228A, 230A, 232A may be less likely to break due to flexure. Inembodiments, the first intermediate element 213 may comprise at leastone of polymeric (e.g. polyurethane, PTFE, PVDF) and ceramic (e.g.alumina, silica) materials.

Additionally or alternatively, the first intermediate element 213 mayreduce the likelihood that more than one of the terminal elements 212are shorted together and/or more than one of the connection parts 222A,224A, 226A, 228A, 230A, 232A are shorted together. For example, thefirst intermediate element 213 may be less moisture absorbent than thefirst adhesive layer 200 (depicted in FIG. 3 ) and/or the maskingelement 218. By being less moisture absorbent, the first intermediateelement 213 may prevent moisture (e.g., sweat, output, etc.) from cominginto contact with one or more of the terminal elements 212 and/or theconnection parts 222A, 224A, 226A, 228A, 230A, 232A via the firstadhesive layer 200 and/or the masking element 218 and, potentially,shorting a combination of the terminal elements 212 together and/or acombination of the connection parts 222A, 224A, 226A, 228A, 230A, 232Atogether.

FIG. 6 is a distal view of an exemplary electrode configuration 220 ofelectrodes 216 of the electrode assembly 204. The electrodeconfiguration 220/electrode assembly 204 comprises a ground electrode222, a first electrode 224, a second electrode 226, a third electrode228, a fourth electrode 230, and a fifth electrode 232. The groundelectrode 222 comprises a ground connection part 222A, and a groundsensing part 222B. The first electrode 224 comprises a first connectionpart 224A. The second electrode 226 comprises a second connection part226A and the third electrode 228 comprises a third connection part 228A.The fourth electrode 230 comprises a fourth connection part 230A and thefifth electrode 232 comprises a fifth connection part 232A. Inembodiments, the plurality of electrodes 216 may be coupled to themonitor device 6 via the connection parts 222A, 224A, 226A, 228A, 230A,232A. In particular, the ground connection part 222A may be connected tothe ground terminal 108 via the ground terminal 282 (illustrated in FIG.10 ), the first connection part 224A may be connected to the firstterminal 110 via the first terminal 284 (illustrated in FIG. 10 ), thesecond connection part 226A may be connected to the second terminal 112via the second terminal 286 (illustrated in FIG. 10 ), the thirdconnection part 228A may be connected to the third terminal 114 via thethird terminal 288 (illustrated in FIG. 10 ), the fourth connection part230A may be connected to the fourth terminal 116 via the fourth terminal290 (illustrated in FIG. 10 ), and the fifth connection part 232A may beconnected to the fifth terminal 116 via the fifth terminal 292(illustrated in FIG. 10 ). In embodiments, the plurality of electrodes216 may be coupled to the monitor device 6 via the connection parts222A, 224A, 226A, 228A, 230A, 232A. As such, the monitor device 6 maymeasure one or more resistances of the plurality of electrodes 216 forvarious purposes as described below. The fourth electrode 230 comprisesfourth sensing parts 230B and the fifth electrode 232 comprises fifthsensing parts 232B. In embodiments, parts of the fourth electrode 230that are not the fourth connection part 230A and/or the fourth sensingparts 230B may be referred to herein as conductor parts of the fourthelectrode 230. Similarly, parts of the fifth electrode 232 that are notthe fifth connection part 232A and/or the fifth sensing parts 232B maybe referred to herein as conductor parts of the fifth electrode 232.Additionally or alternatively, parts of the ground electrode 222 thatare not part of: a resistive pair (e.g., the first, second, and/or thirdresistive pairs 224B, 226B, 228B described in more detail below), theground connection part 222A and/or the ground sensing parts 222B may bereferred to herein as conductor parts of the ground electrode 222.

In embodiments, the first intermediate element 213 (depicted in FIG. 5 )may be arranged between the connection parts 222A, 224A, 226A, 228A,230A, 232A and the first adhesive layer 200. As stated above, byarranging the first intermediate element 213 (depicted in FIG. 5 )between the first adhesive layer 200 and the connection parts 222A,224A, 226A, 228A, 230A, 232A, the connection parts 222A, 224A, 226A,228A, 230A, 232A may be insulated from the first adhesive layer 200.Theground electrode 222 comprises a first electrode part 234 for forming aground for the first electrode 224. The ground electrode 222 comprises asecond electrode part 236 for forming a ground for the second electrode226. The ground electrode 222 comprises a third electrode part 238 forforming a ground for the third electrode 228. The ground electrode 222comprises a fourth electrode part 240 for forming a ground for thefourth electrode 230 and the fifth electrode 232. The fourth electrodepart 240 of the ground electrode 222 comprises ground sensing parts222B.

In view of the foregoing, the first electrode 224 and the firstelectrode part 234 may form a first resistive pair 224B, the secondelectrode 226 and the second electrode part 236 may form a secondresistive pair 226B, and the third electrode 228 and the third electrodepart 238 may form a third resistive pair 228B. Each of the first,second, and third resistive pairs 224B, 226B, 228B may define respectivesensing zones. Each sensing zone may indicate a moisture content of therespective sensing zone.

The moisture content of a respective sensing zone may be indicative ofhow well the first adhesive layer 200 (depicted in FIG. 3 ) is adheringto the skin surface of a user. To determine the moisture content of arespective sensing zone, a resistance between the electrodes included inthe first, second, and/or third resistive pairs 224B, 226B, 228B may besensed by, for example, the monitor device 6 (depicted in FIG. 1 ). And,when the resistance between the electrodes included in the first,second, and/or third resistive pairs 224B, 226B, 228B decreases below athreshold level, the monitor device 6 may send an indication to the userthat the adhesion between the first adhesive layer 200 and the skinsurface of a user may be deteriorating. In embodiments, when theadhesion between the first adhesive layer 200 and the skin surface of auser proximal to the third resistive pair 228B deteriorates, the monitordevice 6 may send a signal to the user suggesting the user changehis/her ostomy appliance 2 and/or base plate 4. Additionally oralternatively, when the adhesion between the first adhesive layer 200and the skin surface of a user proximal to the first resistive pair 224Band/or second resistive pair 226B deteriorates, the monitor device 6 maysend a signal to the user suggesting the user change his/her ostomyappliance 2 and/or base plate 4.

As illustrated in FIG. 6 , the second resistive pair 226B may at leastpartially surround the first resistive pair 224B. Additionally oralternatively, the third resistive pair 228B may at least partiallysurround the second resistive pair 226B. Furthermore, in embodiments,one or more of the first, second, and third resistive pairs 224B, 226B,228B may be arranged circumferentially around the stomal opening 18(depicted in FIG. 1 ) and/or around the center point of the stomalopening 18.

By including different resistive pair 224B, 226B, 228B which at leastpartially surround one another, a monitor device 6 may determine howquickly the adhesion between the first adhesive layer 200 and the skinsurface of a user may be deteriorating. For example, a monitor device 6may determine that at time ti the adhesion between the first adhesivelayer 200 and the skin surface of a user proximal to the first resistivepair 224B is deteriorating by sensing a reduced resistance between theelectrodes included in the first resistive pair 224B. Then, at time t₂the monitor device 6 may determine the adhesion between the firstadhesive layer 200 and the skin surface of a user proximal to the secondresistive pair 226B is deteriorating by sensing a reduced resistancebetween the electrodes included in the second resistive pair 226B. Byknowing how the distance between the first and second resistive pairs226A, 228B, the monitor device 6 may be calculate a velocity by dividingthe distance between the first and second resistive pairs 226A, 228B bythe difference between t₁ and t₂. The computed velocity may thendetermine how much time a user has before the adhesion between the firstadhesive layer 200 and the skin surface of a user proximal to the thirdresistive pair 228B deteriorates, which may be when the user would liketo change his/her ostomy appliance 2 and/or base plate 4.

FIG. 7 is a distal view of an exemplary masking element 218. Inembodiments, the masking layer 218 may by arranged between conductorparts of the ground electrode 222, conductor parts of the fourthelectrode 230, and/or conductor parts of the fifth electrode 232. Thatis, as stated above, the conductor parts of the ground electrode 222 areparts of the ground electrode 222 that are not the ground connectionpart 222A and/or the ground sensing parts 222B. Similarly, the conductorparts of the fourth electrode 230 are parts of the fourth electrode 230that are not the fourth connection part 230A and/or the fourth sensingparts 230B and the conductor parts of the fifth electrode 232 are partsof the fifth electrode 232 that are not the fifth connection part 232Aand/or the fifth sensing parts 232B. Further, because the maskingelement 218 may be more insulative than the first adhesive layer 200,the conductor parts of the ground electrode, the fourth electrode, andthe fifth electrode may be insulated from the first adhesive layer 200.

The masking element 218 optionally has a plurality of terminal openings.For example, the masking element 218 may include one, two, three, four,five, six, seven, etc. terminal openings. In embodiments, the pluralityof terminal openings comprises a ground terminal opening 242, a firstterminal opening 244, a second terminal opening 246, a third terminalopening 248, a fourth terminal opening 250, and a fifth terminal opening252. The terminal openings 242, 244, 246, 248, 250, 252 of the maskingelement 218 are configured to overlap (that is, axially align) withrespective connection parts 222A, 224A, 226A, 228A, 230A, 232A of theelectrodes of the electrode assembly. For example, connection part 222Amay overlap the first terminal opening 244, connection part 224A mayoverlap the second terminal opening 244, connection part 226A mayoverlap the third terminal opening 246, connection part 228A may overlapthe fourth terminal opening 250, connection part 230A may overlap thefifth terminal opening 252, and connection part 232A may overlap thesixth terminal opening 252. While the masking element 218 depicts sixterminal openings, in other embodiments, the masking element 218 mayinclude more or fewer terminal openings.

The masking element 218 has a plurality of sensor point openings. Thesensor point openings comprise primary sensor point openings shownwithin dotted line 254. Each primary sensor point opening is configuredto overlap (that is, axially align with) a ground sensing part 222B ofthe ground electrode 222 and/or a fourth sensing part 230B of the fourthelectrode 230 of the electrode configuration 220. More specifically, inembodiments, the primary sensor point openings shown within dotted line254 comprise, in the illustrated exemplary masking element, five primaryfirst sensor point openings 254A each configured to overlap a groundsensing part 222B of the ground electrode 222. In addition, the primarysensor point openings shown within dotted line 254 comprise, in theillustrated exemplary masking element, four primary second sensor pointopenings 254B each configured to overlap a fourth sensing part 230B ofthe fourth electrode 230. In embodiments, each of the primary sensorpoint openings shown within dotted line 254 may be equal distances froma center point of the stomal opening 18. Alternatively, one or more ofthe primary sensor point openings shown within dotted line 254 may bedifferent distances from a center point of the stomal opening 18. Whilethe illustrated embodiment depicts five primary first sensor pointopenings 254A in the dotted line 254, in other embodiments, the maskingelement 218 includes more or fewer than five primary first sensor pointopenings 254A in the dotted line 254. Additionally or alternatively,while the illustrated embodiment depicts four primary second sensorpoint openings 254B in the dotted line 254, in other embodiments, themasking element 218 includes more or fewer than four primary secondsensor point openings 254B in the dotted line 254.

Additionally or alternatively, the sensor point openings comprisesecondary sensor point openings shown within dotted line 256. Eachsecond sensor point opening is configured to overlap a fourth sensingpart 230B of the fourth electrode 230 and/or a fifth sensing part 232Bof the fifth electrode 232 of the electrode configuration 220. Morespecifically, in embodiments, the secondary sensor point openings shownwithin dotted line 256 comprise, in the illustrated exemplary maskingelement, five secondary first sensor point openings 256A each configuredto overlap a fifth sensing part 232B of the fifth electrode 232. Inaddition, the secondary sensor point openings shown within dotted line256 comprise, in the illustrated exemplary masking element, foursecondary second sensor point openings 256B each configured to overlap afourth sensing part 230B of the fourth electrode 230. In embodiments,each of the secondary sensor point openings shown within dotted line 256may be equal distances from a center point of the stomal opening 18.Alternatively, one or more of the secondary sensor point opening shownwithin dotted line 256 may be different distances from a center point ofthe stomal opening 18. In embodiments, the secondary sensor pointopenings shown within dotted line 256 may be substantially the samedistance from a center point of the stomal opening 18 as the primarysensor point openings shown within dotted line 254. Alternatively, oneor more of the secondary sensor point openings shown within dotted line256 may be different distance(s) from a center point of the stomalopening 18 as one or more of the primary sensor point openings shownwithin dotted line 254. While the illustrated embodiment depicts fivesecondary first sensor point openings 256A in the dotted line 256, inother embodiments, the masking element 218 includes more or fewer thanfive secondary first sensor point openings 256A in the dotted line 256.Additionally or alternatively, while the illustrated embodiment depictsfour secondary second sensor point openings 256B in the dotted line 256,in other embodiments, the masking element 218 includes more or fewerthan four secondary second sensor point openings 256B in the dotted line256.

Additionally or alternatively, the sensor point openings comprisetertiary sensor point openings shown within dotted line 258. Eachtertiary sensor opening is configured to overlap a fifth sensing part232B of the fifth electrode 232 and/or a ground sensing part 222B of theground electrode 222 of the electrode configuration 220. Morespecifically, in embodiments, he tertiary sensor point openings shownwithin dotted line 258 comprise, in the illustrated exemplary maskingelement, five tertiary first sensor point openings 258A each configuredto overlap a fifth sensing part 232B of the fifth electrode 232. Inaddition, the tertiary sensor point openings shown within dotted line258 comprise, in the illustrated exemplary masking element, fourtertiary second sensor point openings 258B each configured to overlap aground sensing part 222B of the ground electrode 222. In embodiments,each of the tertiary sensor point openings shown within dotted line 258may be equal distances from a center point of the stomal opening 18.Alternatively, one or more of the tertiary sensor point opening shownwithin dotted line 258 may be different distances from a center point ofthe stomal opening 18. In embodiments, the tertiary sensor pointopenings shown within dotted line 258 may be substantially the samedistance from a center point of the stomal opening 18 as the primarysensor point openings shown within dotted line 254. Alternatively, oneor more of the tertiary sensor point openings shown within dotted line258 may be different distance(s) from a center point of the stomalopening 18 as one or more of the primary sensor point openings shownwithin dotted line 254. Additionally or alternatively, the tertiarysensor point openings shown within dotted line 258 may be substantiallythe same distance from a center point of the stomal opening 18 as thesecondary sensor point openings shown within dotted line 256.Alternatively, one or more of the tertiary sensor point openings shownwithin dotted line 258 may be different distance(s) from a center pointof the stomal opening 18 as one or more of the secondary sensor pointopenings shown within dotted line 256. While the illustrated embodimentdepicts five tertiary first sensor point openings 258A in the dottedline 258, in other embodiments, the masking element 218 includes more orfewer than five tertiary first sensor point openings 258A in the dottedline 258. Additionally or alternatively, while the illustratedembodiment depicts four tertiary second sensor point openings 258B inthe dotted line 258, in other embodiments, the masking element 218includes more or fewer than four tertiary second sensor point openings258B in the dotted line 258.

While the primary sensor point openings shown within dotted line 254,secondary sensor point openings shown within dotted line 256, andtertiary sensor point openings shown within dotted line 258 are evenlydistributed angularly about the stomal opening 18, in other embodiments,the primary sensor point openings shown within dotted line 254,secondary sensor point openings shown within dotted line 256, andtertiary sensor point openings shown within dotted line 258 may beunevenly distributed angularly about the stomal opening 18 and/orfocused within an angular range about the stomal opening 18 (e.g., 30degrees-330 degrees). However, these are only examples and not meant tobe limiting. Additionally or alternatively, while the illustratedembodiment depicts three sectors of sensor point openings (i.e., theprimary sensor point openings, the secondary sensor point openings, andthe tertiary sensor point openings), in alternative embodiments, themasking element 218 may include more or fewer sectors of sensor pointsopenings. Additionally or alternatively, each sector may be unevenlydistributed about the center point of the stomal opening 18, each sectormay span different angular ranges, which may or may not be the samebetween the sectors, and/or may have different starting angles and/ordifferent ending angles.

FIG. 8 is a distal view of an exemplary first adhesive layer 200 andFIG. 9 is a proximal view of the first adhesive layer of FIG. 8 . Thefirst adhesive layer 200 has a plurality of sensor point openings. Thesensor point openings of the first adhesive layer comprise primarysensor point openings shown within dotted line 260. Each primary sensorpoint opening is configured to overlap a ground sensing part 222B of theground electrode 222 and/or a fourth sensing part 230B of the fourthelectrode 230 of the electrode configuration 220. More specifically, inembodiments, the primary sensor point openings shown within dotted line260 comprise, in the illustrated exemplary first adhesive layer 200,five primary first sensor point openings 260A each configured to overlapa ground sensing part 222B of the ground electrode 222. In addition, theprimary sensor point openings shown within dotted line 260 comprise, inthe illustrated exemplary first adhesive layer 200, four primary secondsensor point openings 260B each configured to overlap a fourth sensingpart 230B of the fourth electrode 230. In embodiments, each of theprimary sensor point openings shown within dotted line 260 may be equaldistances from a center point of the stomal opening 18. Alternatively,one or more of the primary sensor point opening shown within dotted line260 may be different distances from a center point of the stomal opening18. While the illustrated embodiment depicts five primary first sensorpoint openings 260A in the dotted line 260, in other embodiments, thefirst adhesive layer 200 includes more or fewer than five primary firstsensor point openings 260A in the dotted line 260. Additionally oralternatively, while the illustrated embodiment depicts four primarysecond sensor point openings 260B in the dotted line 260, in otherembodiments, the first adhesive layer 200 includes more or fewer thanfour primary second sensor point openings 260B in the dotted line 260.

Additionally or alternatively, the sensor point openings of the firstadhesive layer comprise secondary sensor point openings shown withindotted line 262. Each second sensor point opening is configured tooverlap a fourth sensing part 230B of the fourth electrode 230 and/or afifth sensing part 232B of the fifth electrode 232 of the electrodeconfiguration 220. More specifically, in embodiments, the secondarysensor point openings shown within dotted line 262 comprise, in theillustrated exemplary first adhesive layer 200, five secondary firstsensor point openings 262A each configured to overlap a fifth sensingpart 232B of the fifth electrode 232. In addition, the secondary sensorpoint openings shown within dotted line 262 comprise, in the illustratedexemplary first adhesive layer 200, four secondary second sensor pointopenings 262B each configured to overlap a fourth sensing part 230B ofthe fourth electrode 230. In embodiments, each of the secondary sensorpoint openings shown within dotted line 262 may be equal distances froma center point of the stomal opening 18. Alternatively, one or more ofthe secondary sensor point opening shown within dotted line 262 may bedifferent distances from a center point of the stomal opening 18. Inembodiments, the secondary sensor point openings shown within dottedline 262 may be substantially the same distance from a center point ofthe stomal opening 18 as the primary sensor point openings shown withindotted line 260. Alternatively, one or more of the secondary sensorpoint openings shown within dotted line 262 may be different distance(s)from a center point of the stomal opening 18 as one or more of theprimary sensor point openings shown within dotted line 260. While theillustrated embodiment depicts five secondary first sensor pointopenings 262A in the dotted line 262, in other embodiments, the firstadhesive layer 200 includes more or fewer than five secondary firstsensor point openings 262A in the dotted line 262. Additionally oralternatively, while the illustrated embodiment depicts four secondarysecond sensor point openings 262B in the dotted line 262, in otherembodiments, the first adhesive layer 200 includes more or fewer thanfour secondary second sensor point openings 262B in the dotted line 262.

Additionally or alternatively, the sensor point openings of the firstadhesive layer 200 comprise tertiary sensor point openings shown withindotted line 264. Each tertiary sensor opening is configured to overlap afifth sensing part 232B of the fifth electrode 232 and/or a groundsensing part 222B of the ground electrode 222 of the electrodeconfiguration 220. More specifically, in embodiments, the tertiarysensor point openings shown within dotted line 264 comprise, in theillustrated exemplary first adhesive layer 200, five tertiary firstsensor point openings 264A each configured to overlap a fifth sensingpart 232B of the fifth electrode 232. In addition, the tertiary sensorpoint openings shown within dotted line 264 comprise, in the illustratedexemplary first adhesive layer 200, four tertiary second sensor pointopenings 264B each configured to overlap a ground sensing part 222B ofthe ground electrode 222. In embodiments, each of the tertiary sensorpoint openings shown within dotted line 264 may be equal distances froma center point of the stomal opening 18. Alternatively, one or more ofthe tertiary sensor point opening shown within dotted line 264 may bedifferent distances from a center point of the stomal opening 18. Inembodiments, the tertiary sensor point openings shown within dotted line264 may be substantially the same distance from a center point of thestomal opening 18 as the primary sensor point openings shown withindotted line 260. Alternatively, one or more of the tertiary sensor pointopenings shown within dotted line 264 may be different distance(s) froma center point of the stomal opening 18 as one or more of the primarysensor point openings shown within dotted line 260. Additionally oralternatively, the tertiary sensor point openings shown within dottedline 264 may be substantially the same distance from a center point ofthe stomal opening 18 as the secondary sensor point openings shownwithin dotted line 262. Alternatively, one or more of the tertiarysensor point openings shown within dotted line 264 may be differentdistance(s) from a center point of the stomal opening 18 as one or moreof the secondary sensor point openings shown within dotted line 262.While the illustrated embodiment depicts five tertiary first sensorpoint openings 264A in the dotted line 264, in other embodiments, thefirst adhesive layer 200 includes more or fewer than five tertiary firstsensor point openings 264A in the dotted line 264. Additionally oralternatively, while the illustrated embodiment depicts four tertiarysecond sensor point openings 264B in the dotted line 264, in otherembodiments, the first adhesive layer 200 includes more or fewer thanfour tertiary second sensor point openings 264B in the dotted line 264.

Additionally or alternatively, while the illustrated embodiment depictsthree sectors of sensor point openings (i.e., the primary sensor pointopenings, the secondary sensor point openings, and the tertiary sensorpoint openings), in alternative embodiments, the first adhesive layer200 may include more or fewer sectors of sensor points openings.Additionally or alternatively, each sector may be unevenly distributedabout the center point of the stomal opening 18, each sector may spandifferent angular ranges, which may or may not be the same between thesectors, and/or may have different starting angles and/or differentending angles.

In view of the foregoing, the primary sensor point openings shown withindotted line 254 of the masking element 218 (depicted in FIG. 7 ) mayoverlap the primary sensor point openings shown within dotted line 260of the first adhesive layer 200. More specifically, each of the fiveprimary first sensor point openings 254A may overlap a respective one ofthe five primary first sensor point openings 260A. As such, the groundsensor points 222B, which the five primary first sensor point openings254A and the five primary first sensor point openings 260A overlap, maybe exposed in an axial direction from the proximal surface 200B of thefirst adhesive layer 200. Furthermore, each of the four primary secondsensor point openings 254B may overlap a respective one of the fourprimary second sensor point openings 260B. As such, the fourth sensorpoints 230B, which the four primary second sensor point openings 254Band the four primary second sensor point openings 260B overlap, may beexposed in an axial direction from the proximal surface 200B of thefirst adhesive layer 200. In embodiments, when output spans or bridgesfrom a ground sensor point 222B to a fourth sensor point 230B, a leakmay be detected by, for example, the monitor device 6. Morespecifically, a drop in resistance may be sensed between a ground sensorpoint 222B and a fourth sensor point 230B by the monitor device 6 inresponse to output spanning and/or bridging from a ground sensor point222B to a fourth sensor point 230B.

Additionally or alternatively, the second sensor point openings shownwithin dotted line 256 of the masking element 218 (depicted in FIG. 7 )may overlap the second sensor point openings shown within dotted line262 of the first adhesive layer 200. More specifically, each of the fivesecondary first sensor point openings 256A may overlap a respective oneof the five secondary first sensor point openings 262A. As such, thefifth sensor points 232B, which the five secondary first sensor pointopenings 256A and the five secondary first sensor point openings 262Aoverlap, may be exposed in an axial direction from the proximal surface200B of the first adhesive layer 200. Furthermore, each of the foursecondary second sensor point openings 256B may overlap a respective oneof the four secondary second sensor point openings 262B. As such, thefourth sensor points 230B, which the four secondary second sensor pointopenings 256B and the four secondary second sensor point openings 262Boverlap, may be exposed in an axial direction from the proximal surface200B of the first adhesive layer 200. In embodiments, when output spansor bridges from a fifth sensor point 232B to a fourth sensor point 230B,a leak may be detected by, for example, the monitor device 6. Morespecifically, a drop in resistance may be sensed between a fifth sensorpoint 232B and a fourth sensor point 230B by the monitor device 6 inresponse to output spanning and/or bridging from a fifth sensor point232B to a fourth sensor point 230B.

Additionally or alternatively, the tertiary sensor point openings shownwithin dotted line 258 of the masking element 218 (depicted in FIG. 7 )may overlap the tertiary sensor point openings shown within dotted line264 of the first adhesive layer 200. More specifically, each of the fivetertiary first sensor point openings 258A may overlap a respective oneof the five tertiary first sensor point openings 264A. As such, theground sensor points 222B, which the five tertiary first sensor pointopenings 258A and the five tertiary first sensor point openings 264Aoverlap, may be exposed in an axial direction from the proximal surface200B of the first adhesive layer 200. Furthermore, each of the fourtertiary second sensor point openings 258B may overlap a respective oneof the four tertiary second sensor point openings 264B. As such, thefifth sensor points 232B, which the four tertiary second sensor pointopenings 258B and the four tertiary second sensor point openings 264Boverlap, may be exposed in an axial direction from the proximal surface200B of the first adhesive layer 200. In embodiments, when output spansor bridges from a ground sensor point 222B to a fifth sensor point 232B,a leak may be detected by, for example, the monitor device 6. Morespecifically, a drop in resistance may be sensed between a ground sensorpoint 222B and a fifth sensor point 232B by the monitor device 6 inresponse to output spanning and/or bridging from a ground sensor point222B to a fifth sensor point 232B.

FIG. 10 is a more detailed distal view of a part of the base plate 4.Monitor interface of the base plate comprises the first connector 211.The first connector 211 comprises coupling part 210 configured toreleasably couple the monitor device to the base plate and thus forminga releasable coupling. The first connector 221/monitor interfacecomprises a plurality of terminals formed by respective terminalelements for forming respective electrical connections with respectiveterminals of the monitor device.

In embodiments, the plurality of terminals of the first connector211/monitor interface comprises a ground terminal element 282 forming aground terminal 282A, a first terminal element 284 forming a firstterminal 284, a second terminal element 286 forming a second terminal286A, and a third terminal element 288 forming a third terminal 288A.The monitor interface optionally comprises a fourth terminal element 290forming a fourth terminal 290A and/or a fifth terminal element 292forming a fifth terminal 290. The terminal elements 282, 284, 286, 288,290, 292 contact respective connection parts 222A, 224A, 226A, 228A,230a, 232A of electrodes 222, 224, 226, 228, 230, 232. The use of theterms “first”, “second”, “third” and “fourth”, “primary”, “secondary”,“tertiary” etc. does not imply any particular order, but are included toidentify individual elements. Moreover, the use of the terms “first”,“second”, “third” and “fourth”, “primary”, “secondary”, “tertiary” etc.does not denote any order or importance, but rather the terms “first”,“second”, “third” and “fourth”, “primary”, “secondary”, “tertiary” etc.are used to distinguish one element from another. Note that the words“first”, “second”, “third” and “fourth”, “primary”, “secondary”,“tertiary” etc. are used here and elsewhere for labelling purposes onlyand are not intended to denote any specific spatial or temporalordering. Furthermore, the labelling of a first element does not implythe presence of a second element and vice versa.

Although particular features have been shown and described, it will beunderstood that they are not intended to limit the claimed invention,and it will be made obvious to those skilled in the art that variouschanges and modifications may be made without departing from the spiritand scope of the claimed invention. The specification and drawings are,accordingly to be regarded in an illustrative rather than restrictivesense. The claimed invention is intended to cover all alternatives,modifications and equivalents.

LIST OF REFERENCES

-   1 ostomy system-   2 ostomy appliance-   4 base plate-   6 monitor device-   8 accessory device-   10 server device-   12 network-   14 coupling member-   16 coupling ring-   18 stomal opening-   20 docking station-   22 first connector-   24 user interface-   100 monitor device housing-   101 processor-   102 first interface-   104 second interface-   106 memory-   108 ground terminal of monitor device-   110 first terminal of monitor device-   112 second terminal of monitor device-   114 third terminal of monitor device-   116 fourth terminal of monitor device-   118 fifth terminal of monitor device-   120 coupling part-   121 power unit-   122 antenna-   124 wireless transceiver-   126 loudspeaker-   128 haptic feedback element-   140 sensor unit-   200 first adhesive layer-   200A distal surface of first adhesive layer-   200B proximal surface of first adhesive layer-   202 second adhesive layer-   202A distal surface of second adhesive layer-   202B proximal surface of second adhesive layer-   204 electrode assembly-   204A distal surface of electrode assembly-   204B proximal surface of electrode assembly-   206 release liner-   206A distal surface of the release liner-   206B proximal surface of the release liner-   208 top layer-   208A distal surface of the top layer-   208B proximal surface of the top layer-   209 coupling ring-   210 coupling part of first connector-   211 first connector-   212 terminals of first connector-   213 first intermediate element-   213A distal surface of first intermediate element-   213B proximal surface of first intermediate element-   214 support layer of electrode assembly-   214A distal surface of support layer-   214B proximal surface of support layer-   216 electrodes of electrode assembly-   218 masking element-   218A distal surface of masking element-   218B proximal surface of masking element-   220 electrode configuration-   222 ground electrode-   222A ground connection part-   222B ground sensing part-   224 first electrode-   224A first connection part-   224B first resistive pair-   226 second electrode-   226A second connection part-   226B second resistive pair-   228 third electrode-   228A third connection part-   228B third resistive pair-   230 fourth electrode-   230A fourth connection part-   230B fourth sensing part-   232 fifth electrode-   232A fifth connection part-   232B fifth sensing part-   234 first electrode part of the ground electrode-   236 second electrode part of the ground electrode-   238 third electrode part of the ground electrode-   240 fourth electrode part of the ground electrode-   242 ground terminal opening-   244 first terminal opening-   246 second terminal opening-   248 third terminal opening-   250 fourth terminal opening-   252 fifth terminal opening-   254 primary sensor point openings of masking element-   254A primary first sensor point opening-   254B primary second sensor point opening-   256 secondary sensor point openings of masking element-   256A secondary first sensor point opening-   256B secondary second sensor point opening-   258 tertiary sensor point openings of masking element-   258A tertiary first sensor point opening-   258B tertiary second sensor point opening-   260 primary sensor point openings of first adhesive layer-   260A primary first sensor point opening-   260B primary second sensor point opening-   262 secondary sensor point openings of first adhesive layer-   262A secondary first sensor point opening-   262B secondary second sensor point opening-   264 tertiary sensor point openings of first adhesive layer-   264A tertiary first sensor point opening-   264B tertiary second sensor point opening-   282 ground terminal element-   282A ground terminal-   284 first terminal element-   284A first terminal-   286 second terminal element-   286A second terminal-   288 third terminal element-   288A third terminal-   290 fourth terminal element-   290A fourth terminal-   292 fifth terminal element-   292A fifth terminal

What is claimed is:
 1. An ostomy appliance base plate, the base platecomprising: a first adhesive layer including a stomal opening with acenter point and a proximal surface configured to be attached to a skinsurface of a user; a plurality of electrodes printed entirely on aproximal surface of a flexible support film, the plurality of electrodesarranged on a distal side of the first adhesive layer, each electrodeincluding a sensing part and a conductor part; and a masking elementarranged distal to the first adhesive layer and proximal to theplurality of electrodes, the masking element being more insulative thanthe first adhesive layer, the masking element comprising a plurality ofmasking element sensor point openings extending through the maskingelement, wherein the masking element is arranged between the conductorpart and the first adhesive layer and wherein the plurality of maskingelement sensor point openings overlap the sensing part of the electrodeto form sensor points.
 2. The ostomy appliance base plate of claim 1,wherein a first masking element sensor point opening of the plurality ofmasking element sensor point openings is arranged at a first radialdistance from the center point and a second masking element sensor pointopening of the plurality of masking element sensor point openings isarranged at a second radial distance from the center point, wherein thefirst radial distance is different than the second radial distance. 3.The ostomy appliance base plate of claim 1, wherein a first maskingelement sensor point opening of the plurality of masking element sensorpoint openings is arranged at a first radial distance from the centerpoint and a second masking element sensor point opening of the pluralityof masking element sensor point openings is arranged at a second radialdistance from the center point, wherein the first radial distance is thesame as the second radial distance.
 4. The ostomy appliance base plateof claim 1, the first adhesive layer comprising a plurality of adhesivelayer sensor point openings extending through the first adhesive layer,wherein the plurality of adhesive layer sensor point openings overlapthe sensing part of the electrode to form the sensor points.
 5. Theostomy appliance base plate of claim 4, wherein a first adhesive layersensor point opening of the plurality of adhesive layer sensor pointopenings is arranged at a first radial distance from the center pointand a second adhesive layer sensor point opening of the plurality ofadhesive layer sensor point openings is arranged at a second radialdistance from the center point, wherein the first radial distance isdifferent than the second radial distance.
 6. The ostomy appliance baseplate of claim 4, wherein a first adhesive layer sensor point opening ofthe plurality of adhesive layer sensor point openings is arranged at afirst radial distance from the center point and a second adhesive layersensor point opening of the plurality of adhesive layer sensor pointopenings is arranged at a second radial distance from the center point,wherein the first radial distance is the same as the second radialdistance.
 7. The ostomy appliance base plate of claim 1, wherein theplurality of electrodes form a first resistive pair of electrodes and asecond resistive pair of electrodes, wherein each resistive pair ofelectrodes includes an electrode part of a ground electrode.
 8. Theostomy appliance base plate of claim 7, wherein the second resistivepair of electrodes at least partially surrounds the first resistive pairof electrodes.
 9. The ostomy appliance base plate of claim 7, whereinthe plurality of electrodes form a third resistive pair of electrodes,wherein the third resistive pair of electrodes includes an electrodepart of a ground electrode.
 10. The ostomy appliance base plate of claim9, wherein the third resistive pair of electrodes at least partiallysurrounds the second resistive pair of electrodes.
 11. The ostomyappliance base plate of claim 9, wherein at least one of the firstresistive pair, the second resistive pair, and the third resistive pairis arranged circumferentially around the center point.
 12. The ostomyappliance base plate of claim 1, further comprising a first intermediateelement, wherein the first intermediate element is less compliant thanthe first adhesive layer, wherein each electrode includes a connectionpart and wherein the first intermediate element is arranged between theconnection part of each electrode and the first adhesive layer.
 13. Theostomy appliance base plate of claim 1, wherein each electrode includesa connection part, wherein the masking element comprises a plurality ofterminal openings, and wherein each terminal opening overlaps aconnection part.
 14. The ostomy appliance base plate of claim 1, furthercomprising a second adhesive layer arranged distally of the plurality ofelectrodes.
 15. The ostomy appliance base plate of claim 14, wherein thefirst adhesive layer and the second adhesive layer are comprised ofdifferent ratios of one or more of: polyisobutenes,styrene-isoprene-styrene, and/or hydrocolloids.
 16. An ostomy appliancebase plate, the base plate comprising: a first adhesive layer includinga stomal opening with a center point and a proximal surface configuredto be attached to a skin surface of a user; a plurality of electrodesprinted entirely on a proximal surface of a flexible support film, theplurality of electrodes arranged on a distal side of the first adhesivelayer, each electrode including a sensing part and a conductor part; andwherein the first adhesive layer comprises a plurality of adhesive layersensor point openings extending through the first adhesive layer,wherein the plurality of adhesive layer sensor point openings overlapthe sensing part of the electrode to form the sensor points.
 17. Theostomy appliance base plate of claim 16, wherein a first adhesive layersensor point opening of the plurality of adhesive layer sensor pointopenings is arranged at a first radial distance from the center pointand a second adhesive layer sensor point opening of the plurality ofadhesive layer sensor point openings is arranged at a second radialdistance from the center point, wherein the first radial distance isdifferent than the second radial distance.
 18. The ostomy appliance baseplate of claim 16, wherein a first adhesive layer sensor point openingof the plurality of adhesive layer sensor point openings is arranged ata first radial distance from the center point and a second adhesivelayer sensor point opening of the plurality of adhesive layer sensorpoint openings is arranged at a second radial distance from the centerpoint, wherein the first radial distance is the same as the secondradial distance.
 19. The ostomy appliance base plate of claim 16,further comprising a masking element arranged distal to the firstadhesive layer and proximal to the plurality of electrodes, the maskingelement being more insulative than the first adhesive layer, the maskingelement comprising a plurality of masking element sensor point openingsextending through the masking element, wherein the masking element isarranged between the conductor part and the first adhesive layer andwherein the plurality of masking element sensor point openings overlapthe sensing part of the electrode to form the sensor points.
 20. Theostomy appliance base plate of claim 19, wherein a first masking elementsensor point opening of the plurality of masking element sensor pointopenings is arranged at a first radial distance from the center pointand a second masking element sensor point opening of the plurality ofmasking element sensor point openings is arranged at a second radialdistance from the center point, wherein the first radial distance is thesame as the second radial distance.